Aravind Pseudoexfoliation Study (APEX) I: Intraoperative Results

Abstract

Purpose: : There is a debate over both the intraoperative and late postoperative complications of cataract surgery in eyes with pseudoexfoliation (XFS). There are questions regarding both the rate of capsular rupture, zonular dehiscence, subluxation and late dislocation of IOL’s. To answer this question we performed a prospective 6-armed study at the Aravind Eye Hospitals in eyes undergoing cataract surgery by phacoemulsification (Phaco) without prior clinical lens subluxation. We report herein the intraoperative results.

Methods: : We enrolled subjects with clinical XFS with or without glaucoma without preexisting phacodonesis, requiring Phaco between December 2010 and October 2011. The control group had no XFS and had Phaco. The eyes with XFS were randomized into four groups at the time of IOL implantation: Single piece Acrysof (Alcon Laboratories; Fort Worth, Tx) lenses (SA60AT) with and without CTR (Aurolab; Madurai, India) and 3-piece Acrysof lenses (MA60AC) with and without CTR. Control eyes were randomized to receive either a SA60AT or MA60AC. Eyes are followed intraoperatively, at 1 day, 1, 3 and 6 months, 1 year, and yearly for 10 years.

Results: : We report on the intraoperative results of 662 eyes and 400 controls, mean age 61.4(7.3). Mean IOPs were 14.4(3.3) XFS and 13.9(2.9) (C) (p=0.021). About 55% of catraracts were nuclear sclerotic while 0.4% had only posterior capsular changes. On LOCS III cataract grading, 65% of XFS had nuclear color of 3+ or more compared to 50% of the controls (p<0.001). Nearly 62% of XFS had dilated pupils <7 mm. Complications did not differ between groups: Zonulodialysis in 6(0.9%) XFS and 2 (0.5%) controls; posterior capsular ruptures in (0.8%) XFS and 3 (0.8%) controls; vitreous loss 4 (0.6%) XFS and 2 (0.5%) controls; and dropped lens fragments 2(0.3%) XFS and 1 (0.2%) control.

Conclusions: : This is the first long-term prospective controlled randomized study evaluating the effects of different IOL styles and the presence or absence of a CTR on surgical complications in XFS. All procedures were performed by senior experienced high-volume cataract surgeons. Eyes with XFS without preexisting phacodenesis do not differ initially from control eyes with regard to intraoperative complications. Because of the low complication rate no differences were detected in experienced hands irrespective of IOL type or use of a CTR. Longer follow-up will reveal if lens choice or the use of a CTR is related to clinically significant late complications.

Clinical Trial: : http://www.clinicaltrials.gov NCT01255995

Keywords: cataract • treatment outcomes of cataract surgery • clinical (human) or epidemiologic studies: outcomes/complications